Creso Pharma Ltd’s (ASX:CPH) (FRA:1X8) target acquisition company Halucenex Life Sciences Inc has entered into a consultancy agreement with US-based scientific consultancy HeteroGeneity LLC to progress a US market entry strategy for the potential use and licensing of botanical psilocybin products and compounds.
HeteroGeneity provides strategic and technical assistance to clients conducting R&D and commercialisation of drugs, biologics and medical devices for the US and Canadian markets.
Under the agreement, both parties will conduct a technology assessment to progress a development plan for a new botanical drug under pharmaceutical development for the US market.
This will include advisory around clinical indications, regulatory status of proposed ingredients, sourcing, manufacturing and formulation, compilation of supporting data and intellectual property considerations amongst other initiatives.
“Progressing regulatory approvals”
HeteroGeneity specialises in the regulation, policy and science of complex, heterogeneous mixtures and addresses novel use areas for traditional medicine practice and naturally of historically complex products.
It is at the forefront of regulation in North America and has been instrumental in assisting a number of companies achieve New Drug Approval Applications through the Food and Drug Administration (FDA) for the US market.
Creso non-executive chairman Adam Blumenthal said: “Creso’s Board and management are very pleased that Halucenex is taking steps forward in the early stages to progress a US market entry.
“Having centralised operations in Nova Scotia will provide Halucenex with considerable advantages when undertaking the steps required to progress regulatory approvals and potential discussions with large pharmaceutical groups for the licensing of the group’s psilocybin extracts and compounds.”
“US set to become lucrative market”
The US psychedelic drug market is expected to total US$6.8 billion by 2027 – highlighting an opportunity for Creso Pharma and Halucenex.
Halucenex founder and CEO Bill Fleming said: “The US is set to become the most important and lucrative market for psychedelic medicines as an alternative treatment, so it is imperative that Halucenex begin to plan its market entry now.
“We are very confident that HeteroGeneity is the right partner to assist us moving forward, given their tremendous track record with FDA approvals for new drugs, medical devices and treatments.
“We look forward to working with the group to establish the immediate requirements for the US market.
“We anticipate that the data from our pending phase II clinical trial will play a major role in this and look forward to being able to update shareholders on the commencement of this initiative in the coming months.”
Notably, Halucenex has assembled a market-leading team of consultants and strategic partners, which will provide it with a considerable competitive advantage as it progresses its phase II clinical trial and US market entry.